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| ID | Type | Description | Link |
|---|---|---|---|
| A539770 | Other Identifier | UW Madison | |
| SMPH/SURGERY/OTOLARYNGOLOGY | Other Identifier | UW Madison | |
| Protocol Version 11/20/2024 | Other Identifier | UW Madison | |
| 1R01DC021415 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The goal of this clinical trial is to create a vocal health database of people aged 4-65 with no diagnosed voice pathology. The main question it aims to answer is:
Participants will complete one 60 minute session involving one of three types of aerodynamic interruption.
The primary goals of this research are to develop noninvasive aerodynamic assessments specific to the pediatric population, and to describe differences between healthy and dysphonic pediatric voices between the ages of 4-17 years. An adult cohort (ages 18-65) will function as a comparison group for incomplete interruption. To account for challenges associated with pediatric data collection, we will modify our current devices and methods of aerodynamic assessment to be better suited for use with the pediatric population and aim to increase measurement reliability in younger subjects. Our proposed modifications include shorter trial times, auditory masking, the use of cheek restraints, and gamification.
After identification of optimal data collection conditions for each method, we will compare these in a large group of children with normal voice. These data will be compared to data from children with vocal fold nodules or polyp. All data will be compiled into a pediatric vocal health database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete airflow interruption | Experimental |
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| Incomplete airflow interruption | Experimental |
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| Airflow redirection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete airflow interruption | Device | Participants will produce a sustained vowel into a mouthpiece (with nose-clip) connected to a PVC tube, with a balloon valve |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare subglottic pressure across different airflow interruption methods | Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech | 60 minutes |
| Compare phonation threshold pressure (PTP) across airflow interruption methods | PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps). | 60 minutes |
| Compare laryngeal resistance across airflow interruption methods | Pressure and airflow measurements can be taken and entered into equations (Ps = (LR) U1+ Z1U1 and Ps = (LR)U2+Z2U2) to calculate Laryngeal resistance and Ps. | 90 minutes |
| Compare subglottic pressure between benign vocal fold lesions and normal voices | Subglottic pressure is measured in kPa of leakage of air between the vocal folds and the resistance to that flow during speech | 90 minutes |
| Compare PTP between benign vocal fold lesions and normal voices | PTP is is calculated by subtracting the intraoral pressure at phonation cessation from the subglottal pressure (Ps). | 90 minutes |
| Compare laryngeal resistance between benign vocal fold lesions and normal voices | Pressure and airflow measurements can be taken and entered into equations (Ps = (LR) U1+ Z1U1 and Ps = (LR)U2+Z2U2) to calculate Laryngeal resistance and Ps. | 90 minutes |
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Inclusion Criteria - Healthy Control:
Exclusion Criteria - Healthy Control:
Inclusion Criteria - Abnormal Voice:
Exclusion Criteria - Abnormal Voice:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jack Jiang, MD | Contact | 608-265-7888 | jjjiang@wisc.edu | |
| Owen Wischhoff | Contact | owischhoff@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jack Jiang, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
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| Incomplete airflow interruption | Device | Incomplete airflow interruption uses a Y-shaped device. The participant produces a sustained /a/ into a mouthpiece and air filter connected to the tube. The tube splits into two tubes distally. |
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| Airflow redirection | Device | Participant phonates through a mouthpiece into a PVC tube that splits into two paths. One path is connected to an open balloon valve. When the balloon is inflated and blocks the path, air is redirected into the other path which is gated by a one-way valve. |
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| Compare vocal efficiency between benign vocal fold lesions and normal voices |
Vocal efficiency is calculated using aerodynamic to acoustic power. |
| 90 minutes |
| Compare mean airflow rate between benign vocal fold lesions and normal voices | Mean airflow (I) = Ps / laryngeal resistance (Lr). | 90 minutes |
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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